OcuTerra Reports Publication of OTT166 Safety and Biological Activity Data from Phase 1b Study in Diabetic Eye Disease

BOSTON–()–OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases for which the current standard of care of “watch-and-wait” does not prevent or control the progression of disease, today announced the publication of a paper titled “The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin Inhibitor for the Treatment of Diabetic Eye Disease: A Phase 1b Study” in Ophthalmic Surgery, Lasers and Imaging Retina (OSLI Retina). The data show that OTT166 eyedrops were well-tolerated and demonstrated biological activity, warranting further evaluation for the treatment of diabetic eye disease.

In this Phase 1b, first in human study 44 diabetic retinopathy (DR) patients who had the sight-threatening complication of diabetic macular edema (DME) were administered either a 2.5% or 5% concentration of OTT166 as an eyedrop twice daily for 28 days. Subjects were then monitored for an additional 28 days with no further treatment (observational phase), with 40 subjects completing the trial. As a Phase 1 study, no formal statistical hypothesis was tested. OTT166 was well-tolerated with no evidence of ocular or systemic toxicity, no drug-related serious adverse events reported and generally stable BCVA throughout the study. There was a clinically meaningful reduction in mean and median central retinal thickness (CRT) in both groups combined at the end of the study (-22 / -28 microns, respectively) and 37% were deemed to be clinical responders as judged by three retina specialists reviewing the OCT scans of every patient.). Based on these findings, the Phase 2 DR:EAM study is underway to evaluate safety and efficacy of OTT166 in diabetic retinopathy.

“The data reported from the OcuTerra Phase 1 DR/DME study clearly showed the OTT166 eyedrop was well tolerated and demonstrated a robust biological activity signal worthy of continued evaluation,” said Jeffrey Heier, M.D., Director of the Vitreoretinal Service and Director of Retina Research at Ophthalmic Consultants of Boston (OCB), one of the largest multi-specialty ophthalmology practices in the U.S, and senior author and investigator for the study. “I am encouraged that we are developing a non-invasive treatment alternative that, if approved, I could potentially start my patients on earlier in their disease course and perhaps delay or even prevent the progression of retinopathy to the degree that repeated injections and/or laser would be indicated. As a member of the OcuTerra Scientific Advisory Board and a Phase 2 DR:EAM study investigator, I look forward participating in the next phases of development.”

“Current treatments available to those with serious diabetic eye disease are leave significant unmet medical need, with most patients left to wait until their disease progresses to the late stage, at which time their only options are often invasive and burdensome,” said David Tanzer, M.D., Chief Medical Officer of OcuTerra Therapeutics. “The opportunity to deliver a non-invasive therapeutic to treat DR earlier has the potential to transform standard of care. We are pleased to share these positive results from the completed study, and we look forward to continuing work in the ongoing Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management ) study of OTT166.”

About OTT166

OTT166 is an investigational, novel, patented, potent and selective small molecule RGD integrin inhibitor designed with purpose engineering to have an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. In preclinical studies, OTT166 selectively inhibited key RGD integrin subtypes, including αvβ3, to regulate cellular responses to VEGF and other growth factors known to contribute to development and progression of diabetic retinopathy and other ocular diseases. In early clinical trials in patients with diabetic retinal disease, OTT166 eye drops have demonstrated preliminary evidence of tolerability and biological activity.

About Diabetic Retinopathy

Diabetic retinopathy is the most common diabetic eye disease and the leading cause of vision loss and blindness in American working age adults, which affects over 8 million people in the US1. The current standard of care for diabetic retinopathy is active surveillance or “watch-and-wait”2 until a sight threatening complication arises. When vision deteriorates further due to complications, the patient must generally undergo injections of medication directly into the back of their eye (intravitreal injection) or undergo destructive laser procedures to help stop the growth of new blood vessels and decrease fluid buildup.

About the Phase 1b Clinical Trial

The Phase 1b DR/DME clinical trial (NCT02914613) was a prospective, randomized, double-masked, first-in-human study of OTT166 (formerly designated SF0166) eye drops in patients with DR/DME, i.e. diabetic retinopathy with center-involved diabetic macular edema, conducted at six clinical sites in the United States. The study population included male and female subjects, aged 18 or older, with diabetic macular edema (i.e., retinal thickening secondary to type 1 or type 2 diabetes mellitus with Diabetic Macular Edema (DME) with central subfield thickness ≥ 325 microns (μm) on spectral domain optical coherence tomography [OCT]) and no treatment with anti-vascular endothelial growth factor (VEGF) therapy in the study eye within up to 60 days of study entry. The primary objective was to determine the safety of two different concentrations of OTT166 eye drop when self-administered twice-a-day for 28 days There was a post-treatment, 28-day follow up period.

About the DR:EAM Clinical Trial

DR:EAM is a multicenter, randomized, double-masked clinical trial designed to assess the safety and efficacy of a high and low dose of daily topical administration of OTT166 versus placebo for 24 weeks in approximately 200 adult patients with moderately severe to severe NPDR or mild proliferative diabetic retinopathy with minimal vision loss. The primary efficacy endpoint of the clinical trial is the percentage of patients that have a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS). Additional endpoints of the clinical trial include measuring the prevention of progression to vision-threatening complications, amount of delayed time to intravitreal injection and/or laser treatment, and exploratory imaging endpoints. More information about this trial is available at ClinicalTrials.gov.

About OcuTerra Therapeutics

OcuTerra Therapeutics, Inc. is developing innovative drugs for ophthalmic diseases for which the current standard of care does not prevent or control the [early] progression of disease. Our initial therapeutic candidate, OTT166, administered as an eye drop containing a novel, potent and selective integrin-inhibitor, is in clinical development as an early, non-invasive intervention for diabetic retinopathy, a chronic, progressive disease that is one of the leading causes of vision loss globally. Our goal is to bring transformative treatments to patients and their clinicians who are currently consigned to watch and wait as disease progresses, ultimately requiring medically intensive and invasive therapy. www.ocuterratx.com

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1
Market Scope, Retinal Pharmaceuticals Market Report, 2021

2 American Academy of Ophthalmology: Preferred Practice Pattern for Diabetic Retinopathy, 2019

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